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Pharmacovigilance Operations

Sanofi | Київ | UA

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Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus. Flexible home office policy, with a possibility to work…...

Hamster Kombat
The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. Main responsibilities:
  • Replaces the CSH in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections.
  • Supports the CSH in ensuring that local PV activities are performed in compliance with the PSPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country
  • Supports the CSH in ensuring establishment and maintenance of a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training
  • Acts as Local Safety Officer (LSO) back-up and as such manage, in absence of LSO, the medical safety of assigned GPV local products with under the supervision of the Regions Medical Safety Head (RMSH).
Experience:
  • Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended
  • A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary
  • Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus
  • Experience with Regulatory Agency interactions
Soft skills:
  • Leadership, able to create networks and to collaborate in an international cross-functional environment
  • Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important
  • Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
  • Ability to work in international and transversal teams.
Technical skills:
  • Robust knowledge of pharmacovigilance systems & regulations
  • Sufficient ability to interpret clinical data including safety data
  • Able to evaluate & manage safety signals and define risk management activities
Education:
  • Advanced health care discipline degree (MD, PharmD, PhD, Master of Science, etc.) or equivalent qualification
Languages: Professional English language proficiency What we offer at Sanofi:
  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
  • Access to internal recruitment and development libraries - you can create your own career path within Sanofi; your professional development will be supported purposefully
  • Flexible home office policy, with a possibility to work up to 50% of time from home, where you can easily schedule your office days
  • An attractive package of benefits
  • Employee Assistance Program (mental health support, legal and financial consulting)
  • Gender neutral paid parental leave as well as volunteer days
Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Information :

  • Company : Sanofi
  • Position : Pharmacovigilance Operations
  • Location : Київ
  • Country : UA

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the Pharmacovigilance Operations job info - Sanofi Київ above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies Pharmacovigilance Operations job info - Sanofi Київ in 17-04-2024 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.

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Post Date : 17-04-2024

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